- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02665429
A Quality Improvement Project to Investigate Individual Provider Variation in Opioid Prescribing From the Emergency Department
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Opioid misuse is a known public safety threat and public health problem, both nationwide and in the Commonwealth of Massachusetts. As a part of these efforts, Emergency Department (ED) outpatient prescriptions have been identified as a potential area for improvement. The Massachusetts Hospital Association (MHA), in conjunction with other stakeholders, developed a set of recommendations to address opioid management and prescribing within the ED setting.
This study is timed to coincide with the rollout by UMassMemorial Health Care of a system-wide opioid prescribing practice guideline/policy which mirrors the Massachusetts Hospital Association's guideline. This rollout provides a unique opportunity for a natural experiment related to provider prescribing practices.
This is a quality improvement project with two primary objectives:
- Improve understanding of physician practice patterns related to emergency department (ED) opioid prescribing
- Evaluate the effectiveness of providing individual clinician profile data in influencing behavior change among ED providers, as it relates to their opioid prescribing patterns
There are two corresponding specific aims:
- Quantitatively describe the current state of opioid prescribing by ED clinicians at four UMass Memorial EDs (using prescriptions generated within the ED electronic health information system between February 2014 and the study implementation date). Descriptive statistics being considered for feasibility of study include:
- Number of opioid prescriptions per hundred patients seen
- Percentage of total prescriptions written that are opioids
- Mean or median quantity of pills dispensed per opioid prescription
- Number of prescriptions for long-acting opioid formulations
- Evaluate the effect on prescribing practices of providing individual clinicians with their profile data to illustrate their personal opioid prescribing patterns, relative to the de-identified distribution for all other clinicians in the ED group
This project is timed to coincide with the separately planned implementation of a system-wide opioid prescribing guideline. The guideline implementation is an independent event, but we feel that it presents a unique opportunity for a simultaneous experimental intervention to assess whether providing clinicians with their individual data alters their prescribing practices beyond any effect achieved simply by being subject to the new guideline. Data collected from the electronic medical record and clinician self-reported data about their perceptions of their prescribing practices will be used to evaluate both the effect of the guideline implementation (i.e. comparison of prescribing patterns for all clinicians before and after guideline implementation) and the combined effect of guideline implementation plus individual profile intervention (i.e. comparisons across intervention versus control groups).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Clinton, Massachusetts, Estados Unidos
- UMass Clinton Hospital
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Marlborough, Massachusetts, Estados Unidos
- UMass Memorial Marlborough Hospital
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Worcester, Massachusetts, Estados Unidos
- UMASS Memorial Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provider who practices Emergency Medicine in one or more of four UMass-affiliated EDs (UMassMemorial Medical Center, Marlborough Hospital, and Clinton Hospital), including attending physicians, resident physicians, and advanced practice providers (PAs and NPs).
- Have placed at least one electronic prescription for a medication of interest (namely opioids) in the PulseCheck electronic medical record system during the 12 months prior to the implementation of the opioid guidelines
- Be actively practicing in a UMass-affiliated ED at time of implementation of the guidelines
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Providers who are subject only to the routine implementation of clinical practice guidelines without additional experimental intervention
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Experimental: Intervention
Providers who are subject to routine clinical practice guideline implementation AND receive provider's own individual prescribing data profile intervention ("Individual prescribing data profile and self-assessment")
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Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices.
Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers.
All peer data are de-identified.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in number of opioid prescriptions per hundred patients seen
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in percentage of total prescriptions written that are opioids
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Change in median quantity of pills dispensed per opioid prescription
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Change in number of prescriptions for long-acting opioid formulations
Periodo de tiempo: Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Pre-intervention baseline compared to 1, 2, 3, 6, 9, 12 months post-intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Self-assessment of decile for number of opioid prescriptions per hundred patients seen
Periodo de tiempo: Once, at time of enrollment
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The provider's self-assessment of their decile of number of opioid prescriptions per hundred patients seen, compared to their peers
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Once, at time of enrollment
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Self-assessment of decile for percentage of total prescriptions written that are opioids
Periodo de tiempo: Once, at time of enrollment
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The provider's self-assessment of their decile of their percentage of total prescriptions written that are opioids, compared to their peers
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Once, at time of enrollment
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Self-assessment of decile for median quantity of pills dispensed per opioid prescription
Periodo de tiempo: Once, at time of enrollment
|
The provider's self-assessment of their decile of their median quantity of pills dispensed per opioid prescription, compared to their peers
|
Once, at time of enrollment
|
Self-assessment of decile for number of prescriptions for long-acting opioid formulations
Periodo de tiempo: Once, at time of enrollment
|
The provider's self-assessment of their decile of their number of prescriptions for long-acting opioid formulations, compared to their peers
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Once, at time of enrollment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sean Michael, MD, UMass Memorial Health Care
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H00009241
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Entrega de atención médica
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Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos